US2008226705A1PendingUtilityA1

Gel delivery system for oral administration of medicaments

57
Individually held — no corporate assignee on recordPriority: Mar 31, 2004Filed: Apr 3, 2008Published: Sep 18, 2008
Est. expiryMar 31, 2024(expired)· nominal 20-yr term from priority
Inventors:Richard SolteroThomas J. Colatsky
A61K 31/192A61K 9/0095A61K 9/2095A61K 9/0056A61K 9/2063A61K 45/06
57
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Claims

Abstract

The invention relates to a swallowable delivery device fabricated from a composition including a hydrated polymeric matrix with gelatinous consistency, one or more active ingredients, and optionally one or more stiffening agent. The delivery device is of a size and shape amenable to swallowing with enhanced solubility and controlled release of the active ingredients.

Claims

exact text as granted — not AI-modified
1 . A swallowable delivery device for administering an active agent to subject having difficulty swallowing, the device comprising: 
       a gelatinous matrix component; 
       a stiffening agent; and 
       an active agent, wherein the active agent and stiffening agent are dispersed in the gelatinous matrix component to form a formulation for fabricating into a shaped form for easy swallowability. 
     
     
         2 . The swallowable delivery device of  claim 1 , wherein the shaped form is a segmented form in which each segment includes a predetermined amount of the active agent. 
     
     
         3 . The swallowable delivery device of  claim 1 , wherein the shaped form is an unsegmented elongated form in which the active agent is evenly distributed throughout the form, such that a unit dosage can be obtained by measuring the length of the unsegmented elongated form and removing a section to provide the unit dosage form. 
     
     
         4 . The swallowable delivery device of  claim 1 , further comprising a taste masking coating on an outer surface thereof. 
     
     
         5 . The swallowable delivery device of  claim 1 , wherein the active agent is poorly soluble in the gelatinous matrix component and is provided in a liposome. 
     
     
         6 . The swallowable delivery device of  claim 1 , wherein the active agent comprises drugs, nutraceuticals, nutrition replacement, nutrition supplements, diagnostic compounds, biomarkers, or radiolabeled drugs. 
     
     
         7 . The swallowable delivery device of  claim 1 , wherein the gelatinous matrix component is pharmaceutical grade gelatin, pectins, hydrolyzed celluloses or a combination thereof. 
     
     
         8 . The swallowable delivery device of  claim 1 , wherein the gelatinous matrix component is, selected from low-bloom Type A (170-220 g), Type B (150-200 g), or a mixture of Types A and B. 
     
     
         9 . The swallowable delivery device of  claim 1 , wherein the stiffener component is a gelatin which is different from that of the matrix component, alkylcellulose which is different from the matrix component, sugar alcohols, starches, alginates, hydrogels, or polyvinyl alcohols. 
     
     
         10 . The swallowable delivery device of  claim 10 , wherein the stiffener component enhances the stability of the formulation relative to a corresponding formulation without the stiffening agents. 
     
     
         11 . The swallowable delivery device of  claim 10 , wherein the formulation is stable at room temperature for at least one year. 
     
     
         12 . The swallowable delivery device of  claim 1 , wherein the active agent is encapsulated into pellets, beads, or mini-tabs and dispersed throughout the gelatinous matrix component. 
     
     
         13 . The swallowable delivery device of  claim 12 , wherein at lease two active agents are encapsulated into pellets, beads, or mini-tabs and dispersed throughout the gelatinous matrix component and wherein the active agents are physically separated from each other by the encapsulation. 
     
     
         14 . The swallowable delivery device of  claim 2 , wherein the segment has a shaped form is cylindrical, spherical, worm shaped, bullet shaped or tape shaped. 
     
     
         15 . The swallowable delivery device of  claim 1 , wherein the gelatinous matrix component is pharmaceutical gelatin in a 10% to 20% solution. 
     
     
         16 . A method of administering an active therapeutic agent to a subject, the method comprising:
 providing swallowable delivery device comprising:
 a gelatinous matrix component; 
 a stiffening agent; and 
 an active agent, wherein the active agent and stiffening agent are dispersed in the gelatinous matrix component to form a formulation for fabricating into a shaped form for easy swallowability; and 
   ingesting the shaped form.   
     
     
         17 . The method of  claim 16 , wherein the active agent comprises drugs, nutraceuticals, nutrition replacement, nutrition supplements, diagnostic compounds, biomarkers, or radiolabeled drugs. 
     
     
         18 . The method of  claim 16 , wherein the gelatinous matrix component is pharmaceutical grade gelatin, pectins, hydrolyzed celluloses or a combination thereof. 
     
     
         19 . The method of  claim 16 , wherein the stiffener component is a gelatin which is different from that of the matrix component, alkylcellulose which is different from the matrix component, sugar alcohols, starches, alginates, hydrogels, or polyvinyl alcohols. 
     
     
         20 . The method of  claim 16 , wherein at lease two active agents are encapsulated into pellets, beads, or mini-tabs and dispersed throughout the gelatinous matrix component and wherein the active agents are physically separated from each other by the encapsulation. 
     
     
         21 . The method of  claim 16  wherein the shaped form is cylindrical, spherical, worm shaped, bullet shaped or tape shaped. 
     
     
         22 . The method of  claim 16 , wherein the gelatinous matrix component is pharmaceutical gelatin in a 10% to 20% solution. 
     
     
         23 . The method of  claim 16 , wherein the delivery device is a segmented shaped form which includes multiple unit dosages. 
     
     
         24 . The method of  claim 23 , further comprising breaking or cutting off one or more segments from the segmented shaped form to provide a unit dose. 
     
     
         25 . A kit comprising multiple oral delivery devices for administration of an active therapeutic agent, wherein the oral delivery devices comprises:
 a gelatinous matrix component;   a stiffening agent; and   an active agent, wherein the active agent and stiffening agent are dispersed in the gelatinous matrix component to form a formulation for fabricating into a shaped form for easy swallowability.   
     
     
         26 . A swallowable delivery device in a shaped form for administering an active agent to subject having difficulty swallowing, the device comprising:
 a inactive core comprising a gelatinous matrix component;   a coating positioned on the inactive core, wherein the first coating comprises:
 a gelatinous matrix component; and 
 an active agent, wherein the active agent and stiffening agent are dispersed in the gelatinous matrix component; and 
   an outside coating to mask the taste of the active ingredients.

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